Development and Optimization of Oral Disintegrating Tablets of Esomeprazole Enteric Coated Pellets by QbD Approach

Abstract

Background: The present study aims to Develop and optimize Oral disintegrating tablets (ODTs) containing enteric coated Esomeprazole Magnesium pellets. QbD Approach was applied to investigate Critical Quality Attributes and Critical Process Parameters that ensure Quality of the product. Formulation of enteric coated pellets was done by coating on non-peril seeds in Fluid Bed Coater. Coating was done in three consecutive layers. First layer contains drug Esomeprazole Magnesium and HPMC E5/Kollicoat IR as film forming polymer. Second coat was done to prevent interaction of drug to enteric coat; also, it acts like a base for enteric coat to be more appropriate. Third coat was done with enteric coating polymer Eudragit L30D55. Optimized pellets were characterized for their sphericity, flow properties, SEM analysis, cumulative percentage drug release, drug content, % yield and % drug load. ODTs were prepared by direct compression of pellets with superdisintegrant ODTs were optimized by applying Design of Experiment. Validation of optimized batch was done by check point method. Characterization of ODTs was done for their Hardness, Friability, Tablet size, thickness, content uniformity, cumulative percentage drug release, SEM analysis and intactness of the pellets. Results and Conclusions: Optimized enteric coated pellets having Drug content 66.02 mg/0.5 gm pellets, 13.2 % drug load, 66.26 % yield, less than 5 % CPR up to 2 hours and almost 90 % CPR in the next 1 hour, were used for further preparation of ODTs. prepared ODTs had shown minimum Disintegration time, less than 10 % drug release up to 2 hrs and at least 85 % drug release in the next hour was achieved. In order to demonstrate clinical benefits the formulation can be manufactured at large scale to provide enough quantities for a clinical trial and to investigate the In Vivo performance.